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What Is the Efficacy of Ruxolitinib Versus Vehicle in Atopic Dermatitis?

Significantly more patients receiving ruxolitinib achieved investigator's global assessment treatment success, significant reduction of pruritus

By Dermsquared Editorial Team | October 06, 2021

For adults with atopic dermatitis, ruxolitinib (RUX) cream has superior efficacy versus vehicle and is well tolerated, according to a study published in the October issue of the Journal of the American Academy of Dermatology.

Kim Papp, M.D., Ph.D., from K. Papp Clinical Research and Probity Medical Research in Waterloo, Ontario, Canada, and colleagues examined eight-week efficacy and safety in two phase 3 studies of RUX cream in patients aged 12 years or older with atopic dermatitis for two or more years. Patients were randomly assigned to receive twice-daily 0.75 percent RUX cream, 1.5 percent RUX cream, or vehicle cream for eight continuous weeks in a 2:2:1 ratio.

Overall, 631 and 618 patients in the Topical Ruxolitinib Evaluation Dermatitis Study 1 and Study 2, respectively, were randomly assigned (631 and 577 were analyzed for efficacy). The researchers found that with 0.75 percent RUX cream and 1.5 percent RUX cream, significantly more patients achieved investigator's global assessment treatment success versus vehicle at week 8 (50.0/39.0 percent and 53.8/51.3 percent, respectively, versus 15.1/7.6 percent). Within 12 hours of the first application of 1.5 percent RUX, significant itch reductions were reported versus vehicle. Application site reactions occurred infrequently (<1 percent) and were lower with RUX than with vehicle; none of these reactions were clinically significant.

"Application of RUX cream exhibits antipruritic and anti-inflammatory effects in atopic dermatitis," the authors write. "This unique dual mode of action combined with targeted and optimized delivery to the skin results in impressive efficacy that is both rapid and sustained."

The study was funded by Incyte Corporation, which manufactures ruxolitinib.

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